CompletedNot Applicable

Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.

Poland36 participantsStarted 2023-01-01

Plain-language summary

Commonly the pressure of about 14 mmHg is applied during laparoscopic liver resection (LLR) with moderate neuromuscular blockade. Lowering the pneumoperitoneum pressure combined with deep neuromuscular blockade may sustain optimal operating space with providing better short-term postoperative results. It has been proved in randomized controlled trials in colorectal or bariatric patients, however there is lack of similar data for laparoscopic liver resection. Doubts about lowering the pneumoperitoneum pressure too hasty are supported by apprehension of worse bleeding control during liver parenchyma transection and its impact on postoperative results. The aim of the trial is to assess the impact of standard (14 mmHg; arm 1) versus low (10 mmHg; arm 2) pneumoperitoneum pressure on intraoperative blood loss, what will be the primary outcome. As secondary endpoints following outcomes will be measured: quality of operating space, intraoperative adverse events, quality of recovery, postoperative renal function, 30-day postoperative complications rate, length of hospital stay. The investigators assume that lower pneumoperitoneum provides non-inferior blood loss control during laparoscopic liver resection with better postoperative results.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients scheduled to perform elective laparoscopic major liver resection * Age of 18 years or older * Signed informed consent Exclusion Criteria: * Severe cardiopulmonary disease * Severe renal disease * Liver cirrhosis * Emergency surgery * Pregnancy * Patient's refusal of participation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraoperative blood loss

Timeframe: Intraoperative

Trial details

NCT IDNCT06060899

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-30

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